Innovent preps for Chinese filing after picankibart shines in psoriasis study

2024-05-28

临床结果临床3期临床2期

Innovent Biologics will seek approval in China for its psoriasis candidate picankibart (IBI112) following positive findings from a registrational study. The anti-IL-23p19 antibody met the primary and key secondary endpoints of the Phase III CLEAR-1 study in Chinese patients with moderate-to-severe plaque psoriasis.

The trial enrolled 500 patients who were randomly assigned to either placebo or picankibart 200mg every four weeks at week 0, 4 and 8 followed by 200mg or 100mg every 12 weeks. Co-primary endpoints included the proportion of participants achieving a ≥90% improvement in Psoriasis Area and Severity Index (PASI 90) and those attaining a static Physician's Global Assessment (sPGA) score of clear (0) or almost clear (1) at week 16.

Efficacy onset and maintenance

Results announced Monday showed that 80.3% of picankibart-treated participants achieved PASI 90 and 93.5% achieved sPGA 0 or 1 at week 16, significantly higher than the 2.0% and 13.1% of those receiving placebo, respectively. Moreover, the company also noted sustained skin clearance for picankibart, with 84.9% and 85.9% of participants on the 200mg dose every 12 weeks achieving PASI 90 and sPGA 0 or 1, respectively, at the one-year mark.

Principal investigator Yulin Shi highlighted picankibart’s “short-term onset and long-term maintenance of efficacy,” alongside improved “convenience and adherence” offered by the every-12-week dosing regimen.

Picankibart also demonstrated superiority over placebo on key secondary endpoints, including other measures of psoriasis severity and quality of life. The antibody showed a favourable safety profile as well, with no new safety signals identified.

“There is no IL-23p19 target drug independently developed by Chinese enterprises in the domestic market,” remarked Lei Qian, vice president of clinical development at Innovent, adding that picankibart administered five or six times a year could offer “convenience value as a new treatment option compared to the current…drugs (7-16 times per year).”